Identity
- Trade Name
- CryotopUS-flash(B) FDA UDI
- Generic Name
- Assisted reproduction vitrification carrier FDA UDI
- Device Name
- Cryopreservation storage devices that are intended for use in vitrificationprocedures to contain and maintain human oocytes (MII) and embryos. FDA UDI
- Model / Reference
- CryotopUS-flash(B) FDA UDI
- Description
- Cryopreservation storage devices that are intended for use in vitrificationprocedures to contain and maintain human oocytes (MII) and embryos. FDA UDI
Identifiers
- Catalog Number
- 81184 FDA UDI
- Primary DI / UDI-DI
- 04582231462827 FDA UDI
- 510(k) Number
- K181469 FDA UDI
- FDA Product Code
- MQK FDA UDI
- GMDN Term
- Assisted reproduction vitrification carrier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Assisted reproduction vitrification carrier
CryotopUS-flash(B) by Kitazato Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Assisted reproduction vitrification carrier.
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- CRYOPETTE — ORIGIO INC. · Class II
- Kryo 500 Series Controlled Rate Freezer — PLANER LIMITED · Class I
- VitriGuard — Origio A/S · Class II
- CRYOPETTE — ORIGIO INC. · Class II
Cleared under the same submission
K181469 also covers:
- CryotopUS-flash(G) — KITAZATO CORPORATION
- CryotopUS-flash(R) — KITAZATO CORPORATION
- CryotopUS-flash(W) — KITAZATO CORPORATION
- CryotopUS-flash(Y) — KITAZATO CORPORATION
- CryotopUS-scoop(B) — KITAZATO CORPORATION
- CryotopUS-scoop(G) — KITAZATO CORPORATION
- CryotopUS-scoop(R) — KITAZATO CORPORATION
- CryotopUS-scoop(W) — KITAZATO CORPORATION
- CryotopUS-scoop(Y) — KITAZATO CORPORATION
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kitazato Corporation
Sources (1)
- FDA UDI d7c27e69-c9a3-4a0d-a66c-6389e1da1035 35 fields · synced Jun 6, 2026